Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Pursuant to a preliminary amendment filed February 15, 2023, claims 1-4, 9-11, 14, 16-20, 24, 26-29, 33 and 39-41 are currently pending in the instant application.
Response to Election/Restriction
Applicant's election of Group I, claims 1-4, 9-11, 14, 16-20, 24, 26-29, 33 and 39-41, directed to a method of identifying an agonist or antagonist polypeptide of a biological function; and Applicant’s election of Species with traverse as follows:
Species (A): wherein the agonist or antagonist polypeptide is an agonist or antagonist antibody or an antigen binding fragment thereof (claim 27);
Species (B): wherein the activator is for the positive inducible promoter is introduced into the plurality of nano- or pico-liter droplets subsequent to formation of the plurality of nano- or pico-liter droplets (claim 3);
Species (C): further comprising wherein step (1) is carried out with a nano- or pico-liter droplet-producing microfluidic device (claim 39);
Species (D): said one cell that expresses or is capable of expressing the candidate agonist or antagonist polypeptide (BiTE) is produced by infection at low MOI (claim 26);
Species (E): said candidate agonist or antagonist polypeptide is labeled with a first tracking signal (e.g., Dylight647-conjugated) and co-encapsulated into the nano- or pico-liter droplets in step (1) (claim 33), in the reply filed February 20, 2026 is acknowledged.
Response to Traversals:
The traversal of is on the grounds that: (a) the species recited in claims 3 and 9 are not mutually exclusive because the activator can be introduced both subsequent to the formation of the droplets and via injection or fusion (Applicant Remarks, pg. 2, first full paragraph); and (b) the species recited in claims 24 and 26 are not mutually exclusive (Applicant Remarks, pg. 2, fourth full paragraph).
Regarding (a), regarding claims 3 and 9, claim 3 recites that the activator is an activator for a positive and a negative inducible promoter that is introduced into a plurality of nano- or pico-liter droplets by any method subsequent to formation of the droplets, while the limitations recited in claim 9 encompass any activator, which is introduced at any time into a plurality of nano- or pico-liter droplets via injection or fusion. Thus, the activator, timing of introduction, and the method of introduction into droplets as recited in claim 3 is mutually exclusive from the activator, timing of introduction, and the method of introduction into droplets as recited in claim 9. Additionally, Applicant’s argument is moot. Instant claims 3 and 9 are withdrawn as depending from withdrawn claim 2.
Regarding (b), regarding claims 24 and 26, claim 24 recites that the library of candidate agonist or antagonist polypeptides is a library of candidate BiTEs encoded by a lentiviral vector-based library that is produced by biopanning against an antigen; while claim 26 recites that the candidate agonist or antagonist polypeptide (BiTE) is expressed by one cell and is produced by infection at low MOI, which produces no more than one type of candidate agonist or antagonist. Thus, the limitations as recited in claim 24 are mutually exclusive to the limitations as recited in claim 26. Additionally, Applicant’s argument is moot. Instant claims 24 and 26 are withdrawn as depending from withdrawn claim 20.
Claims 2-4, 9-11, 16-20, 24, 26, 28, 29 and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on February 20, 2026.
The restriction requirement is still deemed proper and is therefore made FINAL.
The claims will be examined insofar as they read on the elected species.
Therefore, claims 1, 14, 27, 33, 39 and 40 are under consideration to which the following grounds of rejection are applicable.
Priority
The present application filed February 15, 2023, claims the benefit of a 35 U.S.C. 371 national stage filing of International Application PCT/CN2021/113823, filed August 20, 2021, which claims the benefit a 35 U.S.C. 371 national stage filing of International Application PCT/CN2020/110616, filed August 21, 2020.
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in the China on August 21, 2020. As well as, Applicant’s filing of a certified copy of PCT/CN2020/110616 as required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on July 19, 2023 and March 5, 2026 have been considered. Initialed copies of the IDSs accompany this Office Action.
Claim Objections/Rejections
Claim Interpretation: each of the plurality of nano- or pico-liter droplets of claim 1 is interpreted to comprise zero or one library cell, and a single reporter cell.
The term “marker” as recited in claim 1 is interpreted to refer to a detectable signal that is a “marker” of any occurrence, any reaction and/or any biological function (e.g., that a reaction has taken place, a reaction has not taken place, binding, cleavage, increased or decreased protein expression, cell apoptosis, cell lysis, etc.).
Claim Objection
Claims 1, 14, 27, 33, 39 and 40 are objected to because of the following informalities: Claims 1, 14, 27, 33, 39 and 40 recite a mixture of pronouns including “the” and “said” within each claim, such that for consistency, a single pronoun reciting either “the” or “said” should be used.
Appropriate correction is required.
Claims 14 and 33 are objected to because of the following informalities: Claims 14 recites the term "T cell line”, “NK cell line” and “GFP” such as recited in claim 14, line 4, where an abbreviation should be spelled out in the first encounter of the claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(B) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 14, 27, 33, 39 and 40 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claims 1, 27 and 33 are indefinite due to the use of use parentheses to comment on or qualify part of the sentences including, for example, “(if present)”; “(e.g., CD40)”; “(e.g., Dylight647-conjugated)”; “(e.g., CellTrace Yellow)”; “(e.g., GFP)”; “(CD40 agonist antibodies)”; and “(reporter cell)”, such as recited in claim 1, line 4 because the one or more claims must particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention. It is unclear whether the limitations in parentheses are meant to be limitations in the claims, whether they are only suggestions, examples of a preferred embodiment, a synonym, or whether they refer to something else. Accordingly, the metes and bounds of the claim are not clear.
Claims 1 and 27 are indefinite for the recitation of the terms “the agonist or antagonist polypeptide” and “said agonist or antagonist polypeptide” in claim 1, lines 7, 11 and 15. There is insufficient antecedent basis for the terms “the agonist or antagonist polypeptide” and “said agonist or antagonist polypeptide” in the claim because claim 1, line 5 recites the term “a candidate agonist or antagonist polypeptide”.
Claim 1 is indefinite for the recitation of the term “suitable condition” such as recited in claim 1, line 10 because the term “suitable” is a relative term that renders the claim indefinite. The term “suitable” is not defined by the claim, and the Specification does not provide a standard for ascertaining the requisite conditions that permit contacting as compared to some other condition that qualifies as an “suitable condition”, such that one of ordinary skill in the art would not be reasonably appraised of the scope of the invention and, thus, the metes and bounds of the claim cannot be determined.
Claim 1 is indefinite for the recitation of the term “to permit said agonist or antagonist to contact the report cell” in claim 1, line 10 because the method is unclear. Instant claim 1 does not recite that the droplets comprise a candidate agonist or antagonist. Additionally, claim 1 does not recite a clear step of contacting a candidate agonist or antagonist with a library cell and/or with a reporter cell, such that it is unclear how the method “identifies an agonist or antagonist polypeptide” of any biological function and, thus, the metes and bounds of the claim cannot be determined.
Claim 1 is indefinite for the recitation of the term “the report cell” in claim 1, line 11. There is insufficient antecedent basis for the term “the report cell” in the claim because claim 1, line 7 recites the term “a reporter cell”.
Claim 1 is indefinite for reciting the terms “isolating or enriching nano- or pico-liter droplets” and/or “the isolated or enriched nano- or pico-liter droplets” such as recited in claim 1, lines 13 and 16 because it is unclear what is isolated or enriched given that “isolation” of a droplet does not identify an agonist or antagonist polypeptide, and “enriching” a droplet does not purify, amplify, and/or identify an agonist or antagonist polypeptide and, thus, the metes and bounds of the claim cannot be determined.
Claim 1 is indefinite for reciting the term “thereby identifying the agonist or antagonist polypeptide” in claim 1, line 15 because it is unclear how a method comprising the steps of “providing” and “maintaining” thereby identifies any agonist or antagonist polypeptide and, thus, the metes and bounds of the claim cannot be determined.
Claim 14 is indefinite for the recitation of the term “said library” in claim 14, lines 1-3. There is insufficient antecedent basis for the term “said library” in the claim because claim 1, line 4 recites the term “no more than one library cell”. Moreover, instant claim 1 does not recite introducing genetic material into a host cells and/or the presence of expression vectors, plasmids, etc. and, thus, the metes and bounds of the claim cannot be determined.
Claim 14 is indefinite for the recitation of the term “a library of expression vectors” such as recited in claim 14, line 2 because claim 14 depends from instant claim 1, wherein claim 1, line 4 recites the term “no more than one library cell”, wherein the “library” is a library of cells, such that the library is not a library of expression vectors or plasmids as recited in claim 14 and, thus, the metes and bounds of the claim cannot be determined.
Claim 14 is indefinite for the recitation of the term “such as” in claim 14, line 2 because the term “such as” is akin to the terms “for example” or “like” (e.g. such as lentiviral vector), such that claim 14 does not specifically point out and distinctly claim what Applicant regards as the invention and, thus, the metes and bounds of the claim cannot be determined. The Examiner suggests that Applicant amend the claim to recite a Markush grouping such as, for example, “a library of expression vectors selected from the group consisting of x, y and z”
Claim 14 is indefinite for the recitation of the term “said library cell” in claim 14, line 3. There is insufficient antecedent basis for the term “said library cell” in the claim because claim 1, line 4 recites the term “no more than one library cell”. The Examiner suggests amending claim 14 to recite, for example, “and/or wherein the no more than one library cell is a cell from a…”.
Claim 33 is indefinite for the recitation of the terms “secondary antibody”; “label”; “first tracking signal”; co-encapsulation; Dylight-conjugated, “step”; “GFP”; tracking; “second, different, tracking signal”; pre-staining, “CellTrace Yellow”; a first and second tracking signal, etc. in claim 33, lines 1-10 because claim 33 depends from instant claims 1 and 27, wherein claims 1 and 27 do not recite the terms indicated supra and, thus, the metes and bounds of the claim cannot be determined.
Claim 33 is indefinite for the recitation of the term “the first and second tracking signals” such as recited in claim 33, line 7. There is insufficient antecedent basis for the term “the first and second tracking signals” in the claim because claim 33, lines 3 and 5-6 recites the term “a first tracking signal” and “a second, different tracing signal.”
Claim 33 is indefinite for the recitation of the term “the first (CD40 agonist antibodies) and the second (reporter cell) tracking signals” such as recited in claim 33, lines 9-10. There is insufficient antecedent basis for the term “the first (CD40 agonist antibodies) and the second (reporter cell) tracking signals” in the claim because claim 33, lines 3 and 5-6 recites the term “a first tracking signal” and “a second, different tracing signal.”
Claim 39 is indefinite for the recitation of the terms “step”; “carrying out”; “droplet-producing microfluidic device”; “inlet”; “oil”; “continuous oil phase”; “aqueous suspension”; “population of said reporter cells”; “population of said cells”; “outlet”; “retrieving”; “junction area”, first, second and third inlets; converging; exiting, etc. in claim 39, lines 1-11 because claim 39 depends from claim 1, wherein claim 1 does not recite any of the terms as indicated supra and, thus, the metes and bounds of the claim cannot be determined.
Claims 39 and 40 are indefinite for the recitation of the term “the first, the second, and the third inlets” such as recited in claim 39, line 9. There is insufficient antecedent basis for the term “the first, the second, and the third inlets” in the claim because claim 39, lines 3, 4 and 5 recite the terms “a first inlet”; “a second inlet”; and “a third inlet.”
Claim 40 is indefinite for the recitation of the terms “droplet-sorting microfluidic device”; “step (3)”; “step (2)”; “bias oil” manifesting a detectable signal; collecting waste; waste; spacing oil; retrieving waste; a “first outlet”; passing; a “sorting actuator”; manifesting a detectable signal; directing the passing of droplets; a “junction area”; forming a stream; converging inlets, etc. because claim 40 depends from claim 1 and 39, wherein claims 1 and 39 do not recite the terms as illustrated supra and, thus, the metes and bounds of the claim cannot be determined.
Claims 39 and 40 are indefinite for the recitation of the term “the first and second outlets” such as recited in claim 39, line 9. There is insufficient antecedent basis for the term “the first and second outlets” in the claim.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 14, 33, 39 and 40 are rejected under 35 U.S.C. 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 14 recites (in part): “wherein said library is a library of expression vectors, such as lentiviral vector, retroviral vector…or plasmid” such as recited in claim 14, lines 1-3 because instant claim 14 depends from instant claim 1, where claim 1 does not recite a library of expression vectors or plasmids; and/or introducing genetic material into a host cells and/or the presence of expression vectors, plasmids, etc. Thus, claim 14 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 33 recites (in part): “wherein a secondary antibody specific for said candidate agonist or antagonist polypeptide…tracking signal and the detectable signal” such as recited in claim 33, lines 1-10 because instant claim 33 depends from instant claims 1 and 27, where claims 1 and 27 does not recite the terms “secondary antibody”; “label”; “first tracking signal”; co-encapsulation; Dylight-conjugated, “step”; “GFP”; “second, different, tracking signal”; pre-staining, “CellTrace Yellow”; a first and second tracking signal, etc. Thus, claim 33 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 39 recites (in part): “wherein step (1) is carried out with a nano- or pico-liter droplet-producing…before exiting through the outlet” such as recited in claim 39, lines 1-11 because instant claim 39 depends from instant claim 1, where claim 39 does not recite the terms “step”; “carrying out”; “droplet-producing microfluidic device”; “inlet”; “oil”; “continuous oil phase”; “aqueous suspension”; “population of said reporter cells”; “population of said cells”; “outlet”; “retrieving”; “junction area”, first, second and third inlets; converging; exiting, etc. Thus, claim 39 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 40 recites (in part): “wherein step (3) is carried out in a nano- or pico-liter droplet-sorting microfluidic device…manifesting said detectable single from the waste” such as recited in claim 40, lines 1-15 because claim 40 depends from instant claims 1 and 39, wherein claims 1 and 39 do not recite “droplet-sorting microfluidic device”; “step (3)”; “step (2)”; “spacing oil”; “bias oil” manifesting a detectable signal; collecting waste; waste; spacing oil; retrieving waste; a “first outlet”; passing; a “sorting actuator”; manifesting a detectable signal; directing the passing of droplets; a “junction area”; forming a stream; converging inlets, etc. Thus, claim 40 is an improper dependent claim for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim, amend the claim to place the claim in proper dependent form, rewrite the claim in independent form, or present a sufficient showing that the dependent claim complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 14, 27, 33, 39 and 40 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. An analysis with respect to the claims as a whole reveals that they do not include additional elements that are sufficient to amount to significantly more than the judicial exception. See Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 134 S. Ct. 2347, 110 U.S.P.Q.2d 1976 (2014); Ass’n for Molecular Pathology v. Myriad Genetics, Inc., 133 S. Ct. 2107, 2116, 106 U.S.P.Q.2d 1972 (2013); Mayo Collaborative Svcs. v. Prometheus Laboratories, Inc., 132 S. Ct. 1289, 101 U.S.P.Q.2d 1961 (2012). See also 2014 Interim Guidance on Patent Subject Matter Eligibility, available at http://www.gpo.gov/fdsys /pkg/ FR-2014- 12-16/pdf/2014-29414.pdf (“2014 Interim Guidance”), and the Office’s examples to be considered in conjunction with the 2014 Interim Guidance in examination of nature-based products, available online at http://www.uspto.gov/patents/law/exam/mdc_examples_nature-based_products.pdf (“Nature-Based Products Examples”). This rejection is proper.
Analysis of subject-matter eligibility under 35 U.S.C. § 101 requires consideration of three issues: (1) whether the claim is directed to one of the four categories recited in §101; (2) whether the claim recites or involves a judicial exception (i.e., a law of nature, natural phenomenon, or natural product); and (3) whether the claim as a whole recites something that amounts to significantly more than the judicial exception. In the instant case, the claims are directed to a natural product, and an abstract idea. Therefore, they must each be considered to determine whether, given their broadest reasonable interpretation, they amount to significantly more than the judicial exception.
The claimed invention is not directed to patent eligible subject matter. Based upon an analysis with respect to the claim as a whole, claims 1, 14, 27, 33, 39 and 40 do not recite something significantly different than a judicial exception. The rationale for this determination is explained below.
In the instant case, the claims are broadly directed to a method of identifying an agonist or antagonist polypeptide of a biological function, the method comprising: (1) providing a plurality of nano- or pico-liter droplets, each comprising: (i) no more than one library cell that expresses or is capable of expressing a candidate agonist or antagonist polypeptide from a library of candidate agonist or antagonist polypeptides; (ii) a reporter cell that, upon contacting the agonist or antagonist polypeptide of the biological function, produces a detectable signal as a marker or indicative of said biological function; (2) maintaining the plurality of nano- or pico-liter droplets under a suitable condition to permit said agonist or antagonist polypeptide to contact the report cell to trigger the biological function, thereby producing said detectable signal; (3) isolating or enriching nano- or pico-liter droplets manifesting said detectable signal, thereby identifying the agonist or antagonist polypeptide of said biological function, within the isolated or enriched nano- or pico-liter droplets.
Beginning with Step I of the analysis, which asks whether the claimed invention falls within a statutory category, such that the instant claims are directed to a natural phenomenon and an abstract idea, thus, the instant claims are directed to a statutory category. Step I: [YES].
Proceeding to Step IIA – Prong One: of the analysis, which asks if the claimed invention is directed to a judicial exception. Instant claims 1, 14, 27, 33, 39 and 40 are drawn to a natural phenomenon in the form of naturally occurring cells that express agonists and/or antagonist polypeptides, and that upon contact with another cell, the agonists and/or antagonists are correlated with a naturally occurring biological function; as well as, being directed to an abstract idea in the form of mathematical concepts (e.g., mathematical relationships, formulas or equations, and/or calculations) and mental process (e.g., observation, judgement and opinion) including the use of a reporter cell; detecting a signal, isolating or enriching nano- or pico-liter droplets, identifying a biological function, etc. The claims are broadly directed to detecting a signal indicative of a biological function when a cell is contacted with a cell that expresses an agonist or antagonist. Step IIA – Prong One [YES].
Step IIA - Prong Two of the analysis asks whether the claim recites additional elements that integrate the exception into a practical application of the exception. In the instant case, the claims are directed to a judicial exception in the form of a natural product and an abstract idea. Claim 1 recites:
“a reporter cell that, upon contacting the agonist or antagonist polypeptide of the biological function, produces a detectable signal as a marker or indicative of said biological function” in lines 7-9; “maintaining the plurality of nano- or pico-liter droplets under a suitable condition to permit said agonist or antagonist polypeptide to contact the report cell to trigger the biological function, thereby producing said detectable signal” in lines 10-12; and “isolating or enriching nano- or pico-liter droplets manifesting said detectable signal, thereby identifying the agonist or antagonist polypeptide of said biological function, within the isolated or enriched nano- or pico-liter droplets” in lines 13-16, which resembles “obtaining and comparing intangible data” (i.e. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 99 U.S.P.Q.2d 1690 (Fed. Cir. 2011)), and are analogous to “organizing information through mathematical correlations” (i.e. Digitech Image Techs., LLC v Electronics for Imaging, Inc., 758 F.3d 1344, 111 U.S.P.Q.2d 1717 (Fed. Cir. 2014)); and are examples of “collecting information, analyzing it, and displaying certain results of the collection analysis” (i.e. Electric Power Group, LLC, v. Alstom, 830 F.3d 1350, 119 U.S.P.Q.2d 1739 (Fed. Cir. 2016)); and resembles “comparing information regarding a sample or test subject to a control or target data” (i.e. Univ. of Utah Research Found. v. Ambry Genetics Corp. (Also known as In re BRCA1– and BRCA2–Based Hereditary Cancer Test Patent Litigation), 774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) or Association for Molecular Pathology v. USPTO (Also known as Myriad CAFC), 689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)). Hence, these limitations are akin to an “abstract idea itself” which was at issue in Alice Corp. and has been identified among non-limiting examples to be an abstract idea. Additionally, the dependent limitations of claim 2 also suffers from the same issue. In other words, the dependent limitations do not rectify the rejection of the independent claim. By way of example, the limitations of claim 27 provides, “
wherein the agonist or antagonist polypeptide is an agonist or antagonist antibody or an antigen binding fragment thereof specific for a cell surface receptor (e.g., CD40) that triggers said biological function”, which are analogous to “obtaining and comparing intangible data” (i.e. CyberSource Corp. v. Retail Decisions, Inc., 654 F.3d 1366, 99 U.S.P.Q.2d 1690 (Fed. Cir. 2011)); “collecting information, analyzing it, and displaying certain results of the collection analysis” (i.e. Electric Power Group, LLC, v. Alstom, 830 F.3d 1350, 119 U.S.P.Q.2d 1739 (Fed. Cir. 2016)); and “comparing information regarding a sample or test subject to a control or target data” (i.e. Univ. of Utah Research Found. v. Ambry Genetics Corp. (Also known as In re BRCA1– and BRCA2–Based Hereditary Cancer Test Patent Litigation), 774 F.3d 755, 113 U.S.P.Q.2d 1241 (Fed. Cir. 2014) or Association for Molecular Pathology v. USPTO (Also known as Myriad CAFC), 689 F.3d 1303, 103 U.S.P.Q.2d 1681 (Fed. Cir. 2012)). Thus, the claims do not integrate the judicial exceptions into a practical application of the exceptions. Step IIA – Prong Two [NO].
Thus, the claims do not integrate the judicial exceptions into a practical application of the exceptions. Step IIA – Prong Two [NO].
Proceeding to Step IIB of the analysis: the question then becomes what element or what combination of elements is sufficient to amount to significantly more than the abstract idea? The instant independent claim is recited at a high level of generality, such that substantially all practical applications of the judicial exception related to new derivatives of antibiotics. For instance, the claims are recited without any specificity as to the method of providing; the size and identity of the nano- or pico-liter droplets (e.g., aqueous, water-in-oil emulsion, w/o/w emulsion, droplet in air, mucus, etc.); the type of library cell; the number of droplets comprising no more than one cell; the candidate agonist or antagonist polypeptide; the reporter cell; the biological function (e.g., protein expression, apoptosis, lysis, cancer remission, cancer cell inducement, etc.); the detectable signal (e.g., fluorescence, optical, electrochemical, colorimetry, etc.); the suitable conditions; whether contacting occurs; trigger of a biological function; the method of maintaining; the method of isolating or enriching; the identity of what is isolated or enriched; how the detectable signal is manifested; the identity of the agonist of antagonist polypeptide, etc., wherein the steps of the method are well known, purely conventional or routine in the art. Step IIB: [NO].
For example, methods for identifying modulatory protein agents (e.g., antibodies or other polypeptides) that regulate phenotypes of eukaryotic cells, wherein a population of cells of a eukaryotic cell type a library of candidate agents (e.g., antibodies or antigen-binding fragments thereof), which will produce a heterogeneous population of modified cells expressing the candidate agents including methods comprising: (1) expressing a library of candidate polypeptide agents in a reporter cell bearing a signaling receptor expressed by the target cell, thereby producing a heterogeneous population of modified, agent-expressing reporter cells, (2) identifying from the heterogeneous population of cells a subpopulation of agent-expressing reporter cells having activated signaling of the receptor, (3) isolating a group of agonist agents from the identified subpopulation of cells, and (4) contacting the group of agonist agents with a population of the target cell and selecting a cell with a specific phenotype indicative of trans-differentiation is known in the art as evidenced by Zhang (US10494438; col 1, lines 44-51; and col 3, lines 7-17); and it is known that a single cell droplet based phenotype assay for identification of Antibody Dependent Cell Mediated Cytotoxicity (ADCC), such that the IgG producing cell (2) secrete an antibody targeting a reporter cell expressing a membrane protein (1), such that after antibody binding on the targeted cell (3), the killing cells (4) are recruited through the cell Fe receptor, which will induce cytotoxic activity (10) mediated through the binding of antibody secreted by (2); as well as, a single cell droplet based phenotype assay for identification of Complement Dependent Cytotoxicity (CDC) antibody, such that the IgG producing cell (2) secretes an antibody targeting a reporter cell expressing a membrane protein (1), wherein after antibody binding on the targeted cell (3), the complement molecules (6) bind to the antibody inducing the cell lysis (10) as evidenced by Reichen (US11427853; col 5, lines 9-26). Moreover, methods for identifying protein modulators of eukaryotic cells by expressing a combinatorial library of potential agonists inside a eukaryotic cell and then directly selecting for an agonist of a target molecule, wherein some methods involve co-culturing a cell expressing a combinatorial library of potential agonists and a second cell, and then selecting agents that modulate a phenotype of or a desired cellular response in the second cell are known in the art as evidenced by Zhang ‘719 (US9738719; Abstract). Thus, methods of identifying an agonist or antagonist polypeptide as recited in claim 1 are well known, purely conventional, or routine in the art including the detection and analysis of proteins associated with preeclampsia. Step IIA [YES].
In sum, when the relevant factors are analyzed, the claims as a whole do NOT recite additional elements that amount to significantly more than the judicial exception itself. Accordingly, claim 1 DOES NOT qualify as eligible subject matter.
Dependent claim(s) 14, 27, 33, 39 and 40 when analyzed as a whole are held to be patent ineligible under 35 U.S.C. 101 because they do not add anything that makes natural product and the abstract idea recited in claim 1 significantly different. For example, claims 2 encompasses the method of claim 1, wherein the modifiers are acylating agents of the group of anhydrides of organic mono – and polycarboxylic acids, but it does not add anything that makes the natural product in claim 1 significantly different. Thus, the claims as a whole do NOT recite additional elements that amount to significantly more than the judicial exception itself.
In light of the above consideration and the new guidance, claims 1, 14, 27, 33, 39 and 40 are non-statutory. This rejection is newly recited as necessitated by the new Guidance set forth in the Memorandum of July 30, 2015 updating the June 25, 2014 guidance (see June 25, 2014 memorandum from Deputy Commissioner for Patent Examination Policy Andrew Hirshfeld titled Preliminary Examination Instructions in view of the Supreme Court Decision in Alice Corporation Pty. Ltd. v. CLS Bank International, et al. (Alice Corp. Preliminary Examination Instructions) and the Revised Patent Subject Matter Eligibility Guidance (See, Federal Register, vol. 84, No. 4, January 7, 2019).
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 14, 27, 39 and 40 are rejected under 35 U.S.C. 102(a1)/102(a2) as being anticipated by Reichen et al. (hereinafter “Reichen”) (US Patent No. 11427853, issued August 30, 2022; and WO2018167218, filed March 15, 2018) as evidenced by Link et al. (hereinafter “Link”) (US Patent No. 8765485, issued July 1, 2014); and Gerard et al. (hereinafter “Gerard”) (International Application WO2017097939, published June 15, 2017).
Regarding claims 1, 27 and 33 (in part), Reichen teaches that Figure 1 shows a single cell droplet based phenotype assay for identification of Antibody Dependent Cell Mediated Cytotoxicity (ADCC), such that the IgG producing cell (2) secrete an antibody targeting a reporter cell expressing a membrane protein (1), such that after antibody binding on the targeted cell (3), the killing cells (4) are recruited through the cell Fe receptor, which will induce cytotoxic activity (10) mediated through the binding of antibody secreted by (2); and the killing cells are isolated from PBMC5 or are cell lines known with cytotoxic mediated activity (interpreted as a reporter cell contacted with an agonist or antagonist antibody expressed by the IgG producing/library cell; triggering cytotoxic activity; producing a detectable signal; and isolating, thereby identifying; and interpreting killing cells as NK cell lines, claims 1 and 2) (col 5, lines 9-19; and Figure 1). Reichen teaches that Figure 2 shows a single cell droplet-based phenotype assay for identification of Complement Dependent Cytotoxicity (CDC) antibody, such that the IgG producing cell (2) secretes an antibody targeting a reporter cell expressing a membrane protein (1), wherein after antibody binding on the targeted cell (3) (interpreted as an antibody), the complement molecules (6) bind to the antibody inducing the cell lysis (10) (interpreted as a reporter cell contacted with an agonist or antagonist antibody expressed by the IgG producing/library cell; triggering cytotoxic activity; producing a detectable signal; isolating, thereby identifying; and an antibody specific for a cell surface receptor, claims 1 and 27) (col 5, lines 20-26; and Figure 2). Figures 1 & 2 are shown below:
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Reichen teaches that Figure 8 shows an example of a standard procedure used for screening of IgG producing cells in droplet, comprising: Step 1: involves B cells and reporter cell preparation, such that the B cell population is preliminarily enriched to increase the relative amount of IgG secreting or producing cells among other type of irrelevant population; Step 2: elicit the co-encapsulation of a single B cell and one single or multi-reporter cell; Step 3: the emulsion containing cells is incubated to let the IgG producing cells secrete the antibody in the droplet (co-encapsulating no more than one library cell, and a reporter cell); Step 4A: a sorting is applied to the population of interest evolving the isolation of IgG specific antibody inducing specific phenotype function (binding, ... ) (biological function); Step 4B: an emulsion containing reagents for performing a reverse transcription (RT) in droplet is prepared in parallel of the 4A step; Step 5: the sorted droplets are dispensed inside a microfluidic device, containing a plurality of reservoir; and the sorted droplet will be trapped by buoyancy inside the microfluidic device; Step 6: the trapped droplet containing cells and presenting the phenotype of interest, are then imaged by using an epifluorescence-based microscope or any other device for fluorescence and/or luminescence acquisition (signal detection); Step 7: in a subsequent step the emulsion produced at the Step 4B is dispensed inside the microfluidic device and fused as one single sorted droplet is fused with one single RT droplet; Step 8: an incubation step is performed to allow the reverse transcription, eventually coupled to PCR reaction, to occur; Step 9: after incubation, the microfluidic device is imaged by using an epifluorescence-based microscope or any other device for fluorescence and/or luminescence acquisition (detecting a signal); Step 10: emulsion trapped in the microfluidic device is recovered and eventually processed for library amplification by PCR (enrichment); Step 11: the amplified libraries is sent for sequencing, such that after completing this entire process two steps of data analysis are performed, which is related to the Steps 6 and 9, the images are analyzed following three general steps, image correction, detection of each individual well/signal and the signal analysis giving the phenotype of the said droplet (interpreted as providing droplets; no more than one library cell; a reporter cell; contacting; maintaining; isolating or enriching droplets; detectable signal; identifying an antagonist or antagonist polypeptide; biological function; and microfluidic device; detectable signals; labels; tracking signals; and co-encapsulation, claims 1 and 33) (col 6, lines 36-66). Reichen teaches that among biological events, detection of a drug effect can be monitored by detecting ADC (Antibody Drug Conjugate) induced by secretion of antigen-specific antibody (see FIG. 3) (interpreted as biological function; and antigen-specific antibody, claims 1 and 27) (col 17, lines 44-46; and Figure 3). Reichen teaches that the "droplet" or "the plurality of droplets" such as the "plurality of RT droplets" or the "plurality of single cell droplets" have an average volume of less than 5 nL, 4 nL, 3 nL, 2.5 nL, 2 nL, 1.5 nL, 1 nL, 0.5 nL, for example 0.1 nL to 3 nL, typically, 10 pL, 20 pL, 30 pL, 50 pL, 0.1 nL, 0.5 nL, 1 nL, etc. including an average volume of 1 pL to 5000 pL (interpreted as nano-liter or pico-liter droplets, claim 1) (col 13, lines 57-67; and col 14, lines 1-3). Reichen teaches that the term “T cell receptor” refers to an antigen-recognition molecule present on the surface of T cells (interpreted as T cell line; and cell surface receptor, claims 1, 14 and 27) (col 10, lines 61-63). Reichen teaches that detection/assay reagents can include stains, dyes, labels, enzymes, substrates, cofactors, and/or specific binding partners (SBP), among others (interpreted as staining, claim 33) (col 48, lines 27-29).
Regarding claim 14, Reichen teaches that the cell is a mammalian cell, an engineered mammalian cell or a cell line or a mammalian immune cell, such that the mammalian cell is an immune cell, wherein an immune cell can be, but is not limited to, B cells, T cells, or hybridomas, wherein the term “T cell receptor” refers to an antigen-recognition molecule present on the surface of T cells (interpreted as T cell line, NK cell line, and encompassing tumor cell lines, claims 1, 14 and 27) (col 10, lines 61-63; and col 20, lines 1-7). Reichen teaches that the patent application that techniques for preparing RT droplets comprising a reverse transcriptase and at least one oligonucleotide can be easily derived by the skilled in the art from the same disclosures, for example PCT/EP2016/080341, where plasmid constructs, and methods can include an expression vector that contains the necessary control sequences or regulatory elements for expression of the antibodies including antibody fragments in bacterial or eukaryotic cells are known in the art as evidenced by Gerard (pg. 43, lines 8-10).
Regarding claims 39 and 40, Reichen teaches that the present invention is also directed to a microfluidic process for barcoding single cell nucleic acids, said method comprising: providing a microfluidic device comprising a chip comprising at least one microfluidic channel and a plurality of reservoirs, injecting into the inlet of the microfluidic channel a carrier fluid comprising a plurality of droplets of a first type dispersed in the carrier fluid, wherein the droplets of the first type are either single cell droplets or RT droplets, wherein at least some of the RT droplets comprise a reverse transcriptase and at least one oligonucleotide, and wherein at least some of the single cell droplets comprise one single cell, wherein said single cell comprises single cell nucleic acids, for a plurality of reservoirs, a first migration step, wherein at least one droplet of the first type among the plurality of droplets is moved into one reservoir of said plurality of reservoirs by buoyancy, injecting into the inlet of the microfluidic channel, a carrier fluid comprising a plurality of droplets of a second type dispersed in the carrier fluid, wherein the droplets of the second type are either single cell droplets or RT droplets, and wherein the droplets of the second type are RT droplets when the droplets of the first type are single cell droplets or the droplets of the second type are single cell droplets when the droplets of the first type are RT droplets, for a plurality of reservoirs, a second migration step, wherein, at least one part of at least one droplet of the second type enters into one reservoir of said plurality of reservoirs, for a plurality of reservoirs, fusing, in or at the edge of each reservoir, said at least one droplet of the first type with said at least one droplet of the second type, thereby resulting in a fused droplet (interpreted as a microfluidic device; a first, second, third inlet; and a population of cells, claim 39) (col 4, lines 14-49). Reichen teaches an outlet channel, wherein the outlet of the channel can be connected to at least one reservoir to collect the fluid coming from the channel (interpreted as an outlet channel, claim 39) (col 11, lines 56-57 and 65-67). Reichen teaches that single cell droplets or RT droplets are prepared prior to injection in a separate microfluidic device, wherein single cell droplets or RT droplets are typically prepared in a microfluidic device having one inlet for a droplet carrier oil (carrier fluid), and additional inlets for components of the droplet aqueous phase (interpreted as a continuous oil phase; and a plurality of inlets, claim 39) (col 15, lines 56-61). Reichen teaches that those of ordinary skill in the art will be aware of techniques for preparing microfluidic droplets, where techniques for encapsulating cells within microfluidic droplets are described for example in U.S. Pat. Nos. 7,708,949, 8,337; 778, 8,765,485, or Int. Pat. Apl. Pub. Nos. WO2004/091763 and WO2006/096571, PCT/EP2016/080341 each incorporated herein by reference (interpreting microfluidics to comprise junctions, claim 39) (col 15, lines 45-51), wherein it is known that electrodes can be positioned near the junction of channels, and Figure 13B illustrates the fusion of droplets as evidenced by Link (col 14, lines 53-57). Figure 13B of Link is shown below:
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Reichen does not specifically exemplify a secondary antibody (claim 33, in part).
Reichen meets all the limitations of the claims and, therefore, anticipates the claimed invention.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and
103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for
the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1, 14, 27, 33, 39 and 40 are rejected under 35 U.S.C. 103 as being unpatentable over Reichen et al. (hereinafter “Reichen”) (US Patent No. 11427853, issued August 30, 2022; and WO2018167218, filed March 15, 2018) in view of Zhang et. al. (hereinafter “Zhang”) (US Patent No. 10494438, issued December 3, 2019; previously published as US20180002425, published January 4, 2018) as evidenced by Link et al. (hereinafter “Link”) (US Patent No. 8765485, issued July 1, 2014); and Gerard et al. (hereinafter “Gerard”) (International Application WO2017097939, published June 15, 2017).
The teachings of Reichen regarding claims 1, 14, 27, 33 (in part), 39 and 40 is discussed supra.
Reichen does not specifically exemplify a secondary antibody (claim 33, in part).
Regarding claim 33 (in part), Zhang teaches that the invention provides methods for identifying protein modulators (e.g., antibody agonists) of eukaryotic cells, wherein the methods typically involve expressing a combinatorial agent library (e.g., via lentiviral vectors) inside a eukaryotic cell type (e.g., a mammalian cell) and then directly selecting for agents (e.g., antibodies) that are agonist of a target molecule (e.g., a signaling receptor) that modulates a phenotype of or elicits a cellular response in the cell, wherein some related methods involve co-culturing a cell expressing a combinatorial agent library and a second cell, and then selecting agents that modulate a phenotype of or elicit a cellular response in the second cell (Abstract, lines 1-3). Zhang teaches that the agents are antibodies and are introduced into and expressed in the starting cells under conditions each individual cell expresses no more than 3 different members of the antibody library; as well as, methods for identifying protein agonists that capable of reprograming or trans-differentiating a target cell, where also provided in the invention are specific agonist antibodies of signaling receptors or biomolecules that modulate a phenotype or effectuate a cellular response in a eukaryotic cell (e.g., agonist antibodies of EpoR, TpoR or G-CSFR) (Abstract, lines 13-23). Zhang teaches immunofluorescence staining, where cells were fixed with 4% paraformaldehyde (PFA) at room temperature for 20 min, blocked and stained with 1 ng/mL anti-human IgGl Fc:PE antibody for 30 min at RT; cells were also permeabilized with 0.1 % Triton in PBS at RT for 20 min, and incubated with anti-human IgGl Fc:PE antibody for 30 min at RT, such that after washing in blocking solution three times for 15 min images were collected using a Zeiss inverted fluorescence microscope (interpreted as a secondary antibody, claim 33) (col 36, lines 4-12).
“It is prima facie obvious to combine prior art elements according to known methods to yield predictable results; the court held that, "…a conclusion that a claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. KSR International Co. v. Teleflex Inc., 550 U.S. ___, ___, 82 USPQ2d 1385, 1395 (2007); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atlantic & P. Tea Co. v. Supermarket Equipment Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950)”. Therefore, in view of the benefits of identifying protein modulators of eukaryotic cells as exemplified by Zhang, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to modify the method for barcoding nucleic acids from single cells and processes for genotyping single cells having a phenotype of interest including through co-encapsulating an IgG producing cells that secrete an antibody targeting a reporter cell, and a reporter cell as disclosed by Reichen to include the antibody agonists, vectors, and incubation with secondary antibodies as taught by Zhang with a reasonable expectation of success in identifying protein agonists and/or antagonists that modulate a phenotype or elicit a cellular response in a heterogenous population of cells expressing one or more candidate agents.
Thus, in view of the foregoing, the claimed invention, as a whole, would have been obvious to one of ordinary skill in the art at the time the invention was made. Therefore, the claims are properly rejected under 35 USC §103 as obvious over the art.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 14, 27, 33, 39 and 40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over: claims 1-20 of copending US Patent Application No. 18/054,823.
US18/054,823 teaches: a screening method comprising: (a) detecting the presence and/or level of expression of a reporter molecule in a single, isolated, genetically engineered cell, wherein the cell presents a cell surface protein; and wherein the cell is engineered to: (i) secrete a heterologous test polypeptide; and (ii) express a reporter molecule if the test polypeptide activates the cell surface protein, or express a reporter molecule if the test polypeptide does not activate the cell surface protein (claim 1); and a screening method comprising: (a) contacting a single, isolated, genetically engineered cell with a test reagent comprising a reporter molecule, wherein the cell presents a cell surface protein; wherein the test reagent is capable of binding the cell surface protein presented by the cell, forming a reagent protein complex, and wherein the test reagent gains entry into the cell when the reagent-receptor complex is formed; wherein the cell is engineered to: (i) secrete a heterologous test polypeptide; (b) detecting the presence and/or level of expression of the reporter molecule in the cells (claim 17).
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims encompass a method of identifying an agonist or antagonist polypeptide of a biological function, comprising: providing a plurality of nano- or pico-liter droplets, each comprising: no more than one library cell capable of expressing a candidate agonist or antagonist from a library; and a reporter cell; maintaining the plurality of nano- or pico-liter droplets; and isolating or enriching nano- or pico-liter droplets manifesting a detectable signal.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1, 14, 27, 33, 39 and 40 are rejected.
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/AMY M BUNKER/Primary Examiner, Art Unit 1684